负载质量对低温气化过氧化氢（VHP）灭菌过程中物理参数的影响（英文版）.pdf

1、1The Effects of Load Mass on the Physical Parameters during Low-temperature Vaporized Hydrogen Peroxide(VHP)Sterilization ProcessesAiqin Chen/Xu JuAffiliation:CSSD/Department of Infection ControlSun Yat-Sen University Cencer CenterEmail:2CONTENT1.Research Background2.Method3.Result4.Discussion and C

2、onclusion5.Further Research6.Research Basis31.Research Background1.1 Low-temperature vaporized hydrogen peroxide(VHP)sterilizerVariation in VHP sterilizer performance1Variation in load weight requirements 2 Multiple Manufacturers and models Wide variation in performance Standard:Manufacturers specif

3、y load mass limits Manuals of some brands:Lack the information In practice:Users may overload Overloading Higher BI positivityA Survey among 106 hospitals in southern China(Apr May 2023)41.Research Background1.1 Low-temperature vaporized hydrogen peroxide(VHP)sterilizerExample of sterilization pract

4、ice:Load mass limits in user manualActual load mass(STANDARD cycle)Loading mass and method seemed appropriateActually:load mass exceeded the manual limit All physical parameters,Chemical indicators,Biological Indicators were qualified!About 30%Overweight!Cycle TypeMax.load mass（Kg）ShelvesSTANDARD9.7

5、1 or 2FLEX9.71 or 2DUO61 or 2EXPRESS4.9Bottom shelf onlyInstrumentsMass（Kg）Total（Kg）1 ultrasound probe package51 3D scope package4.54 optical scope packages312.551.Research Background1.2 Research basisRequirements for load mass in VHP sterilizationin current international and national standardsISO 2

6、2441-20221GB 27955-202026.3 The load configuration shall strictly follow the user manual of the sterilizer to avoid improper loading that may affect sterilization efficacy.1 ISO.Sterilization of health care products Low temperature vaporized hydrogen peroxide Requirements for the development,validat